Organizer

Location

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:

Design and TPP

Pre-clinical testing and comparability

Clinical testing

Analytical studies

Stability of biosimilar products

Why you should attend :

The regulation of Biosimilars is very complex and the approach used by various regions differs. Professionals working in this complex area should be equipped with the latest knowledge and keep abreast of current and new legislation and requirements in this field in order to gain market access for their products.

Areas Covered in the Session:

his course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes:

Design and TPP

Pre-clinical testing and comparability

Clinical testing

Analytical studies

Stability of biosimilar products

Who Will Benefit:

Regulatory Affairs

Medical Officers

Clinical Trial Managers

---------------------------------------------------------------------
Please contact the event manager Marilyn below for the following:
- For Registrations Please call +1 929.900.1853
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

QualityStabilityPre-clinical testingCASE STUDY 1 - Including a walkthrough of expected outcomes for all case study exercisesWrap up of day 1 & Q&A's

Day 2 Schedule

Lecture 1:

Clinical aspects

Phase I Phase IIILecture 2:

Important guidelines

Clinical testing SafetyLecture 3:

Registration process EMA

Walk through the EU Centralized registration process What to look out for Project managementLecture 4:

Market access for Biosimilars

HTA in Europe/USCASE STUDY 2 � Including a walkthrough of expected outcomes for all case study exercisesWrap up of day 2 & Q&A's

Speaker Details

Salma Michor

PhD, MSc, MBA, CMgr, RAC

Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King's College, University of London in food technology; and an MBA from Open University, and has earned the RAC (EU), CQA and is a Chartered manager.